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CLARINEX-D 12 HOUR is a combination product containing an H1-receptor antagonist and a sympathomimetic amine indicated for: Relief of nasal and non-nasal symptoms of seasonal allergic rhinitis, including nasal congestion, in adults and adolescents 12 years of age and older. (1)
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2 Dosage And Administration
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For oral use only Adults and adolescents 12 years of age and over: The recommended dose of CLARINEX-D 12 HOUR Extended Release Tablets is one tablet twice a day. (2)
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Hypersensitivity (4) Narrow Angle Glaucoma (4) Urinary Retention (4) Patients Receiving MAO Inhibitors or within 14 days of stopping such treatment (4) Severe hypertension or severe coronary artery disease (4)
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3 Dosage Forms And Strengths
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Desloratadine 2.5 mg/Pseudoephedrine sulfate 120 mg tablets. (3)
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5 Warnings And Precautions
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Cardiovascular and central nervous system effects: Use with caution in patients with cardiovascular disorders. (5.1). Coexisting conditions: Use with caution in patients with increased intraocular pressure, prostatic hypertrophy, diabetes mellitus, or hyperthyroidism (5.2).
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The most common adverse reactions (reported in ≥2% of patients) were insomnia, headache, mouth dry, fatigue, somnolence, pharyngitis, dizziness, nausea, insomnia and anorexia. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Schering Corporation at 800-526-4099 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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Monoamine Oxidase (MAO) Inhibitors: Do not use. May potentiate the effect of pseudoephedrine on vascular system. (7.1)
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8 Use In Specific Populations
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Renal impairment: Avoid in patients with renal impairment (8.6) Hepatic impairment: Avoid in patients with hepatic impairment (8.7)
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9 Drug Abuse And Dependence
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Created by
fda_medical_bot
on
1/7/2012
